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Wellness Intervention for Menstrual Mood Disorders (WIMM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Susan Girdler, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01995916
First received: November 7, 2013
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

This study has been funded by National Institute of Mental Health (NIMH) to compare two behavioral interventions for Menstrual Mood Disorders, including premenstrual dysphoric disorder (PMDD). Both of these interventions will be run in a group format, meaning that you will be part of a group of other women who have a menstrual mood disorder. Both of these interventions will be run by experienced mental health professionals and both interventions have been shown to be effective in reducing mood symptoms, increasing a sense of well-being, and helping individuals cope with stress. While it is expected that both interventions to be associated with some benefit, this study is designed to see which is better for women with a menstrual mood disorder.


Condition Intervention
Menstrual Mood Disorders
Behavioral: Mindfulness Intervention
Behavioral: Social Support Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Intervention for Menstrual Mood Disorders & Early Life Abuse: BioPsych Mechanisms

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Change in Premenstrual Depression Symptomatology and Functional Impairment [ Time Frame: Baseline, 8 weeks intervention, 6 months follow up ] [ Designated as safety issue: No ]
    Premenstrual depression symptoms will be assessed prospectively before, during and for 6 months after the intervention using Daily Record of Severity of Problems (DRSPs). Functional impairment will be assessed via questionnaire at baseline, at 2 week intervals throughout the intervention, and monthly during the follow-up phase.

  • Change in Cold Pain Sensitivity [ Time Frame: Lab 1 before the start of the intervention, Lab 2 immediately following intervention, Labs 3 and 4 during month 3 and 6 of follow up phase ] [ Designated as safety issue: No ]
    Sensitivity to a cold pressor pain test (hand submerged in ice water) will be assessed in a laboratory setting before and after the intervention, and again 3 and 6 months later


Secondary Outcome Measures:
  • Change in premenstrual anxiety, irritability and total symptom severity [ Time Frame: Baseline, 8 weeks intervention, 6 months follow up ] [ Designated as safety issue: No ]
    Symptoms will be assessed prospectively through Daily Record of Severity of Problems (DRSPs).

  • Change in sensitivity to the temporal summation of heat pain test [ Time Frame: Lab 1 before the start of the intervention, Lab 2 immediately following intervention, Labs 3 and 4 during month 3 and 6 of follow up phase ] [ Designated as safety issue: No ]
    Sensitivity to a temporal summation of heat pain test will be assessed in a laboratory setting before and after the intervention, and again 3 and 6 months later


Estimated Enrollment: 140
Study Start Date: August 2013
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness Intervention
Mindfulness Based Stress Reduction Intervention
Behavioral: Mindfulness Intervention
The Mindfulness Group will meet once a week for 2.5 hours for 8 weeks with a half day retreat.
Active Comparator: Social Support Group
Social Support Group Intervention
Behavioral: Social Support Group
The Social Support Group will meet once a week for 2.5 hours for 8 weeks with a half day retreat.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets prospective criteria for a menstrual mood disorder, including PMDD
  • Depression symptom severity and functional impairment based on prospective symptom ratings for 2-3 cycles using the Daily Record of Severity of Problems (DRSP)
  • Clear remission of all symptoms during days 6-10
  • 18 - 55 years of age
  • Regular menstrual cycles
  • Early life sexual or physical abuse (50% of sample) or no history of sexual or physical abuse (50% of sample)
  • Absence of current PTSD symptoms using the 17-item PTSD checklist (PCL)
  • 8th grade literacy level
  • Ability to give informed consent

Exclusion Criteria:

  • Current Axis I disorder or suicide ideation (histories of depression, anxiety, substance abuse, and eating disorders are allowed if in remission for >2 years)
  • Premenstrual exacerbation of chronic disorders
  • In a current abusive relationship or residing with a former abuser
  • A lifetime history of suicide attempt, or suicidal thoughts or gestures within 5 years of study enrollment
  • Histories of bipolar or psychotic disorders
  • Age < 18 or > 55 years
  • Pregnancy or breastfeeding
  • Use of psychotropic, hormonal or other agents that alter mood or biological mediators
  • Current functional pain disorder
  • A history of meditation practice (2+ times/week for 15+ min; some yoga allowed)
  • Diabetes
  • BMI < 18.5
  • Vigorous exercise
  • Stage 2 Hypertension
  • Any symptom item rated >2 (moderate or higher) or a total score > 24 on the PTSD checklist
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01995916

Contacts
Contact: Khanh Nguyen 919-966-2547 khanh_nguyen@med.unc.edu

Locations
United States, North Carolina
UNC Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Khanh Nguyen    919-966-2547    khanh_nguyen@med.unc.edu   
Principal Investigator: Susan Girdler, PhD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Susan Girdler, PhD UNC- Chapel Hill
  More Information

Additional Information:
No publications provided

Responsible Party: Susan Girdler, PhD, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01995916     History of Changes
Other Study ID Numbers: 13-1867, 1R01MH099076-01A1
Study First Received: November 7, 2013
Last Updated: June 5, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Disease
Mood Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014